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NCT05633654ClinicalTrials.gov

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or…

المرحلة 3مطلوب 1,514 مشاركاً372 موقعاً11 دولة

الفئات

علم الأورام81%الأمراض الجلدية19%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2022-12-01; recorded start 2022-12-12
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 162 other studies in this databaseCounted from the lead sponsor named in the record (Gilead Sciences)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 356 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,514 participants (target), run at 372 sites, across 11 countries.

How this score is built
  • Enrolment32/40

    1,514 participants (target)

  • Site count25/25

    356 sites

  • Country count12/15

    11 countries

  • Planned duration10/10

    Planned over about 105 months

  • Sponsor scale9/10

    Gilead Sciences has led 164 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

الحالات

  • Triple Negative Breast Cancer

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Key Inclusion Criteria: * Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery: * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)). * Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery. * Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment. * Adequate organ function. Key Exclusion Criteria: * Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer. * Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment. * Evidence of recurrent disease following preoperative therapy and surgery. * Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor. * Individuals with germline breast cancer gene (BRCA) mutations. * Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of \< 50% * Active serious infections requiring anti-microbial therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 1,514 مشاركاً

الجهة الراعية والمتعاونون

  • Gilead Sciences الجهة الراعية
  • Alliance Foundation Trials, LLC. المتعاونون
  • NSABP Foundation Inc المتعاونون
  • GBG Forschungs GmbH المتعاونون

الأذرع والتدخلات

  • Sacituzumab govitecan-hziy (SG) + PembrolizumabEXPERIMENTAL

    Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

  • Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + CapecitabineACTIVE_COMPARATOR

    Participants will receive one of the following TPC regimens determined prior to randomization: * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

التدخلات

  • دواء Capecitabine

    Tablets administered orally

  • دواء Pembrolizumab

    Administered intravenously

  • دواء Sacituzumab govitecan-hziy (SG)

    Administered intravenously

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Invasive Disease-free Survival (iDFS)

    iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.

    الإطار الزمني Up to 60 months

  2. مقياس النتيجة الثانوي

    Overall Survival (OS)

    OS is defined as the time from the date of randomization until death due to any cause.

    الإطار الزمني Up to 96 months

  3. مقياس النتيجة الثانوي

    Distant Disease-free Survival (dDFS)

    dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.

    الإطار الزمني Up to 60 months

  4. مقياس النتيجة الثانوي

    Recurrence-free Survival (RFS)

    RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.

    الإطار الزمني Up to 60 months

  5. مقياس النتيجة الثانوي

    Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    الإطار الزمني First dose date up to 38 months plus 30 days

  6. مقياس النتيجة الثانوي

    Percentage of Participants Experiencing Laboratory Abnormalities

    الإطار الزمني First dose date up to 38 months plus 30 days

  7. مقياس النتيجة الثانوي

    Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores

    TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.

    الإطار الزمني Up to 60 months

التواريخ

تاريخ البدء12 ديسمبر 2022 (فعلي)
الإتمام الأولي1 يونيو 2027 (تقديري)
الإتمام1 أغسطس 2031 (تقديري)
أول نشر1 ديسمبر 2022 (فعلي)
آخر تحديث9 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

278 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Cancer Research SAAdelaideSouth Australiaقيد التجنيد
Bendigo HealthBendigoVictoriaقيد التجنيد
Cairns HospitalCairnsQueenslandقيد التجنيد
Macarthur Cancer Therapy Centre, Campbelltown HospitalCampbelltownNew South Walesقيد التجنيد
Monash Medical CentreClaytonVictoriaقيد التجنيد
Kinghorn Cancer CentreDarlinghurstNew South Walesقيد التجنيد
Townsville University HospitalDouglassQueenslandقيد التجنيد
Lake Macquarie Private HospitalGatesheadNew South Walesقيد التجنيد
Fiona Stanley HospitalMurdochWestern Australiaقيد التجنيد
Port Macquarie Base HospitalPort MacquarieNew South Walesقيد التجنيد
Princess Alexandra HospitalWoolloongabbaQueenslandقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Institut Jules BordetAnderlechtنشط، دون تجنيد
AZ KlinaBrasschaatنشط، دون تجنيد
Chirec Delta HospitalBrusselsقيد التجنيد
Grand Hopital de Charleroi asbl (GHdC)Gillyنشط، دون تجنيد
Jessa ZiekenhuisHasseltقيد التجنيد
UZ LeuvenLeuvenقيد التجنيد
Clinique CHC MontLégiaLiègeقيد التجنيد
AZ Delta vzwRoeselareقيد التجنيد
AZ VitazSint-Niklaasنشط، دون تجنيد
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS AugustinusWilrijkقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, BrasilBrasíliaقيد التجنيد
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130Curitibaقيد التجنيد
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, ParanáCuritibaنشط، دون تجنيد
OncositeIjuíقيد التجنيد
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, BrasilItajaíقيد التجنيد
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RNNatalقيد التجنيد
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340Porto Alegreقيد التجنيد
Av. Ipiranga 6690Porto Alegreقيد التجنيد
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , BrasilPorto Alegreقيد التجنيد
Hospital Esperança SARecifeنشط، دون تجنيد
Instituto Santa Joana Recife de Ensino e PesquisaRecifeنشط، دون تجنيد
Instituto D'Or de Pesquisa e Ensino - RJRio de Janieroنشط، دون تجنيد
Av. Milton Santos, 123 - Ondina, Salvador - BA, , BrasilSalvadorقيد التجنيد
AMO Clinic - Rio VermelhoSalvadorنشط، دون تجنيد
Instituto D'Or de Pesquisa e Ensino SPSão Pauloنشط، دون تجنيد
Hospital Sirio Libanês - SPSão Pauloنشط، دون تجنيد
Av. Brigadeiro Luís Antônio 733, loja 8São Pauloقيد التجنيد
Martiiano de Carvalho 965São Pauloقيد التجنيد
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer CenterSão Pauloقيد التجنيد
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200Teresinaقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
CHU Amiens PicardieAmiensقيد التجنيد
Pôle Santé Léonard De Vinci - ROC37Chambray-lès-Toursقيد التجنيد
Institut de Cancerologie de BourgogneDijonقيد التجنيد
Clinique Victor HugoLe Mansقيد التجنيد
chu de LimogesLimogesقيد التجنيد
Institut de Cancérologie de l'Ouest (ICO) - St HerblainLoire Atlantiqueقيد التجنيد
Hôpital Privé Jean MermozLyonقيد التجنيد
Centre D'Oncologie de GentillyNancyقيد التجنيد
L'Hôpital Privé du ConfluentNantesقيد التجنيد

يُدرَج 322 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 9 سبتمبر 2026

    أُضيف موقع

    16 sites added (372 total)

    356372

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05633654